Senior Director, Regulatory CMC Strategy
Humacyte, Inc.
Humacyte, Inc. in Durham, North Carolina seeks a Senior Director, Head of Regulatory CMC. The role requires deep expertise in biological and cell therapy products to lead strategy and compliance for complex manufacturing processes, reporting directly to the Chief Regulatory Officer. Responsibilities include regulatory submissions, team management, risk identification, and maintaining compliance with FDA and international regulations. The ideal candidate has at least 8 years of director-level experience in Regulatory CMC, strong communication skills, and a BS degree in a biologics-related discipline. The role offers a competitive salary, stock options, and comprehensive benefits. #J-18808-Ljbffr Humacyte, Inc.
- ...more information, visit JOB SUMMARY We are seeking a Senior Director, Head of Regulatory CMC with deep expertise in biological and cell therapy products... ...and CMC regulatory requirements. This role will lead strategy, compliance, and submissions for complex manufacturing...SeniorTemporary workLocal areaVisa sponsorship
- ...and antagonists. Summary The Director (Senior Director), Regulatory Affairs will be responsible for... ...implementation of global regulatory strategies for assigned programs in alignment with... ...responsibility for submissions that include CMC documentation. Experience with...SeniorLocal areaWorldwide
- ...Job Description Job Description Director / Senior Director, Regulatory Affairs About the Role The company... ...execution of worldwide regulatory strategy across assigned programs, keeping all... ...oversight of submissions containing CMC documentation. Background in drug...SeniorWorldwide
$190k - $260k
Shattuck Labs, Inc. is seeking a Director (Senior Director), Regulatory Affairs in Durham, NC. This role requires a minimum of 8 years of regulatory... ...pharmaceutical industry and involves overseeing global regulatory strategies for drug development. The successful candidate will...Senior- ...or Preconstruction Manager. This role involves critical pre-construction planning, managing estimates, and overseeing budgets and strategies. Ideal candidates will have over 5 years of experience and a strong grasp of commercial construction practices. The position...Senior
- Senior Manager, University Talent Insights & StrategySkip to main content#Senior Manager, University Talent Insights & Strategy page is loaded## Senior Manager, University Talent Insights & StrategyApplylocations... ...regulations of numerous self-regulatory organizations, including FINRA,...Senior
- ...next phase of growth and is seeking a Senior Manager, Regulatory Affairs who can operate successfully in... ...professional who enjoys both strategy and execution. You will help shape the... ...provide practical guidance on clinical, CMC, device, nonclinical, labeling, and lifecycle...Senior3 days per week
$129.3k - $227.3k
...experience together. Role Overview This role sits within the Product Strategy & Operations team and acts as a strategic partner to Product... ..., pressure‑test assumptions, and influence decisions at the senior leadership level. You will be exposed to all aspects of the...SeniorWork from homeFlexible hours$203k - $253k
Teleflex is seeking a Senior Director, Strategic Regulatory Affairs & UDI, based in Morrisville, NC. This role leads global regulatory operations, ensuring... ...candidate will empower teams, develop organizational strategies, and partner with various functions to drive business...$105k - $135k
...engage with Proposition Owners and team leaders. This role, equivalent to a Senior Manager, plays a vital part in developing and delivering services aligned with audience needs and engagement strategies. With over 8 years of experience in marketing and a user-centric...Senior$107.9k - $172.64k
Blue Cross NC is seeking a Senior Business Architect in Durham, North Carolina. This critical role requires expertise in business consulting and the ability to translate enterprise strategies into actionable plans. Candidates should have a Bachelor’s degree or advanced...Senior- Habitat For Humanity Of Durham is seeking a Senior Business Architect who will play a critical role in shaping the enterprise strategy and aligning investments to strategic priorities. This highly visible role requires business consulting and strategy development, working...Senior
- IQVIA Argentina in Durham, United States, seeks a Senior Director for Strategic Planning to guide development in the Research & Development Solutions division. This role involves overseeing strategic planning, conducting market intelligence efforts, and facilitating mergers...SeniorRemote job
$107.9k - $172.64k
Blue Cross and Blue Shield of North Carolina is seeking a Senior Business Architect to link enterprise strategy with actionable business capabilities. This pivotal role involves collaborating with various departments to assess and validate initiatives, ensuring strategic...SeniorFlexible hours$123.8k - $198k
A global technology firm is seeking a Senior Product Manager to lead its mainframe software division. This role involves guiding product strategy, collaborating with various teams, and maintaining customer relationships. The ideal candidate should have over 10 years of...Senior- IQVIA Argentina is seeking a Principal for COA Strategy Consulting to lead client projects and business development in a collaborative environment. This role involves developing strategies for complex client needs and mentoring team members. The ideal candidate has over...Senior
$184k - $233k
Lenovo is seeking a Sr. Manager of Product Management in Morrisville, North Carolina. This remote role focuses on leading the product strategy and roadmap for AI platforms, collaborating with various internal teams. Candidates should have at least 8 years of management...SeniorRemote job- ...providing quality assurance support for Chemistry, Manufacturing, and Controls (CMC) operations. Key duties include batch release review, deviation assessments, and supporting regulatory compliance. The ideal candidate will have a Bachelor’s degree in a life sciences...SeniorWork at office
$129.3k - $227.3k
..., Inc. is seeking an analytical individual to join their Product Strategy & Operations team. This role focuses on driving strategic decisions, shaping growth strategies, and delivering insights to senior leadership. Ideal candidates will possess strong analytical, communication...SeniorFlexible hours$140k - $155k
...technical depth and strategic thinking. The position requires extensive Salesforce experience and offers a hybrid work model. Salary ranges from $140,000 - $155,000 with additional benefits. Join a team committed to data-driven marketing strategies. #J-18808-Ljbffr PearsonSeniorFull time$130k - $180k
...communication skills. The ideal candidate will lead high-impact projects and act as a trusted advisor to clients, ensuring successful data strategies and implementations. Competitive compensation includes a salary range of $130,000 to $180,000, along with comprehensive benefits...SeniorFlexible hours$180k - $240k
Labcorp is seeking a Senior Director of Product Management for MyLabcorp Consumer to lead the digital product vision and ensure alignment with business goals. This full-time role offers a hybrid work schedule for those within 35 miles of Durham, NC. The ideal candidate...SeniorFull time$186.3k
Job Overview The Senior Medical Director provides strategic medical and scientific subject matter experience and expertise to IQVIA in the specialty... ...plans and is responsible for the execution of the group strategy and leads the strategic direction of the Center of...SeniorFull timePart timeImmediate start- ## Senior Manager, NIL Partnership Strategy - University of North Carolina at Chapel HillApplylocations: Chapel Hill, NCtime type: Full timeposted on: Posted Yesterdayjob requisition id: R101244Tar Heel Sports Properties is seeking an experienced and strategic Senior Manager...SeniorTemporary workWork at officeLocal areaFlexible hoursWeekend workAfternoon shift
$195.75k - $326.25k
Sr. Director, Hepatology/Immunology Strategic Engagement & Portfolio... ...& Portfolio/Pipeline Strategy leads the integrated U.S. commercial... ...actionable recommendations for senior leadership and cross-... ...compliance with policies, SOPs, and regulatory requirements.Proactively...SeniorLocal area- ## Senior GPS & PV, Quality Control, Compliance & Training ManagerApplyremote type: Hybridlocations... ...of Global Patient Safety (GPS) training strategies, with a focus on training operations,... ...training programs are aligned with regulatory requirements, evolving business...SeniorWork at office3 days per week
$140k - $200k
A leading digital consultancy is seeking an experienced Associate Principal, CX Application Strategy, to drive digital transformation initiatives. In this hybrid role based in Durham, NC, you will lead efforts in enhancing customer experience through AI and technology...$109.2k - $273k
...evidence (RWE) studies that inform clinical development strategy, including generating evidence to address regulatory questions related to safety profiles and evidence... ...and Phase 3 programs. This position requires a senior-level epidemiologist to provide scientific...SeniorFull timePart timeImmediate startRemote workWorldwide$107.9k - $172.64k
## Senior Strategic Advisor, Health Plan StrategyApplylocations: Remote Flex - North Carolinatime... ...mission, vision and activate the strategy across multiple time horizons. Support a... ...analyze and monitor relevant industry, regulatory, technology and market based trends to...SeniorWork at officeLocal areaRemote workFlexible hours2 days per week$203k - $253k
...information, visit teleflex.com . Position Summary The Senior Director, Strategic Regulatory Affairs & UDI provides leadership and oversight for... ...This role is accountable for establishing organizational strategy, operational excellence, governance frameworks, and organizational...SeniorTemporary workWork at officeFlexible hours
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